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Article: Combination of a cyclo-oxygenase-2 inhibitor and a proton-pump inhibitor for prevention of recurrent ulcer bleeding in patients at very high risk: a double-blind, randomised trial
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TitleCombination of a cyclo-oxygenase-2 inhibitor and a proton-pump inhibitor for prevention of recurrent ulcer bleeding in patients at very high risk: a double-blind, randomised trial
 
AuthorsChan, FKL2
Wong, VWS2
Suen, BY2
Wu, JCY2
Ching, JYL2
Hung, LCT2
Hui, AJ2
Leung, VKS1
Lee, VWY2
Lai, LH2
Wong, GLH2
Chow, DKL2
To, KF2
Leung, WK2
Chiu, PWY2
Lee, YT2
Lau, JYW2
Chan, HLY2
Ng, EKW2
Sung, JJY2
 
Issue Date2007
 
PublisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/lancet
 
CitationLancet, 2007, v. 369 n. 9573, p. 1621-1626 [How to Cite?]
DOI: http://dx.doi.org/10.1016/S0140-6736(07)60749-1
 
AbstractBackground: Guidelines on pain management recommend that patients at risk of ulcers receive either a cyclo-oxygenase (COX 2) inhibitor or a non-steroidal anti-inflammatory drug (NSAID) with a proton-pump inhibitor (PPI). These two treatments have similar effectiveness, but they are insufficient for protection of patients at very high risk for ulcer bleeding. We aimed to test the hypothesis that in patients with previous ulcer bleeding induced by non-selective NSAIDs, combined treatment with the COX 2 inhibitor celecoxib and the PPI esomeprazole would be better than celecoxib alone for prevention of recurrent ulcer bleeding. Methods: 441 consecutively presenting patients who were taking non-selective NSAIDs for arthritis were recruited to our single-centre, prospective, randomised, double-blind trial after admission to hospital with upper-gastrointestinal bleeding. Patients were enrolled after their ulcers had healed and a histological test for Helicobacter pylori was negative. All patients were given 200 mg celecoxib twice daily. 137 patients were randomly assigned to receive 20 mg esomeprazole twice daily (combined-treatment group), and 136 to receive a placebo (control group) for 12 months. The primary endpoint was recurrent ulcer bleeding during treatment or within 1 month of the end of treatment. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00365313. Findings: Combination treatment was more effective than celecoxib alone for prevention of ulcer bleeding in patients at high risk. The 13-month cumulative incidence of the primary endpoint was 0% in the combined-treatment group and 12 (8·9%) in the controls (95% CI difference, 4·1 to 13·7; p=0·0004). The median follow-up was 13 months (range 0·4-13·0). Discontinuation of treatment and the incidence of adverse events were similar in the two treatment groups. Interpretation: Patients at very high risk for recurrent ulcer bleeding who need anti-inflammatory analgesics should receive combination treatment with a COX 2 inhibitor and a PPI. Our findings should encourage guideline committees to review their recommendations for patients at very high risk of recurrent ulcer bleeding. © 2007 Elsevier Ltd. All rights reserved.
 
ISSN0140-6736
2013 Impact Factor: 39.207
 
DOIhttp://dx.doi.org/10.1016/S0140-6736(07)60749-1
 
ReferencesReferences in Scopus
 
DC FieldValue
dc.contributor.authorChan, FKL
 
dc.contributor.authorWong, VWS
 
dc.contributor.authorSuen, BY
 
dc.contributor.authorWu, JCY
 
dc.contributor.authorChing, JYL
 
dc.contributor.authorHung, LCT
 
dc.contributor.authorHui, AJ
 
dc.contributor.authorLeung, VKS
 
dc.contributor.authorLee, VWY
 
dc.contributor.authorLai, LH
 
dc.contributor.authorWong, GLH
 
dc.contributor.authorChow, DKL
 
dc.contributor.authorTo, KF
 
dc.contributor.authorLeung, WK
 
dc.contributor.authorChiu, PWY
 
dc.contributor.authorLee, YT
 
dc.contributor.authorLau, JYW
 
dc.contributor.authorChan, HLY
 
dc.contributor.authorNg, EKW
 
dc.contributor.authorSung, JJY
 
dc.date.accessioned2012-09-05T05:27:19Z
 
dc.date.available2012-09-05T05:27:19Z
 
dc.date.issued2007
 
dc.description.abstractBackground: Guidelines on pain management recommend that patients at risk of ulcers receive either a cyclo-oxygenase (COX 2) inhibitor or a non-steroidal anti-inflammatory drug (NSAID) with a proton-pump inhibitor (PPI). These two treatments have similar effectiveness, but they are insufficient for protection of patients at very high risk for ulcer bleeding. We aimed to test the hypothesis that in patients with previous ulcer bleeding induced by non-selective NSAIDs, combined treatment with the COX 2 inhibitor celecoxib and the PPI esomeprazole would be better than celecoxib alone for prevention of recurrent ulcer bleeding. Methods: 441 consecutively presenting patients who were taking non-selective NSAIDs for arthritis were recruited to our single-centre, prospective, randomised, double-blind trial after admission to hospital with upper-gastrointestinal bleeding. Patients were enrolled after their ulcers had healed and a histological test for Helicobacter pylori was negative. All patients were given 200 mg celecoxib twice daily. 137 patients were randomly assigned to receive 20 mg esomeprazole twice daily (combined-treatment group), and 136 to receive a placebo (control group) for 12 months. The primary endpoint was recurrent ulcer bleeding during treatment or within 1 month of the end of treatment. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00365313. Findings: Combination treatment was more effective than celecoxib alone for prevention of ulcer bleeding in patients at high risk. The 13-month cumulative incidence of the primary endpoint was 0% in the combined-treatment group and 12 (8·9%) in the controls (95% CI difference, 4·1 to 13·7; p=0·0004). The median follow-up was 13 months (range 0·4-13·0). Discontinuation of treatment and the incidence of adverse events were similar in the two treatment groups. Interpretation: Patients at very high risk for recurrent ulcer bleeding who need anti-inflammatory analgesics should receive combination treatment with a COX 2 inhibitor and a PPI. Our findings should encourage guideline committees to review their recommendations for patients at very high risk of recurrent ulcer bleeding. © 2007 Elsevier Ltd. All rights reserved.
 
dc.description.natureLink_to_subscribed_fulltext
 
dc.identifier.citationLancet, 2007, v. 369 n. 9573, p. 1621-1626 [How to Cite?]
DOI: http://dx.doi.org/10.1016/S0140-6736(07)60749-1
 
dc.identifier.doihttp://dx.doi.org/10.1016/S0140-6736(07)60749-1
 
dc.identifier.epage1626
 
dc.identifier.issn0140-6736
2013 Impact Factor: 39.207
 
dc.identifier.issue9573
 
dc.identifier.pmid17499604
 
dc.identifier.scopuseid_2-s2.0-34248216918
 
dc.identifier.spage1621
 
dc.identifier.urihttp://hdl.handle.net/10722/163078
 
dc.identifier.volume369
 
dc.languageeng
 
dc.publisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/lancet
 
dc.publisher.placeUnited Kingdom
 
dc.relation.ispartofLancet
 
dc.relation.referencesReferences in Scopus
 
dc.subject.meshAged
 
dc.subject.meshAnti-Inflammatory Agents, Non-Steroidal - Adverse Effects - Therapeutic Use
 
dc.subject.meshAnti-Ulcer Agents - Adverse Effects - Therapeutic Use
 
dc.subject.meshCyclooxygenase Inhibitors - Adverse Effects - Therapeutic Use
 
dc.subject.meshDouble-Blind Method
 
dc.subject.meshDrug Therapy, Combination
 
dc.subject.meshFemale
 
dc.subject.meshHumans
 
dc.subject.meshMale
 
dc.subject.meshOmeprazole - Adverse Effects - Therapeutic Use
 
dc.subject.meshOsteoarthritis - Drug Therapy
 
dc.subject.meshPeptic Ulcer Hemorrhage - Chemically Induced - Prevention & Control - Therapy
 
dc.subject.meshProton Pumps - Antagonists & Inhibitors
 
dc.subject.meshPyrazoles - Adverse Effects - Therapeutic Use
 
dc.subject.meshRecurrence - Prevention & Control
 
dc.subject.meshRisk Factors
 
dc.subject.meshSulfonamides - Adverse Effects - Therapeutic Use
 
dc.subject.meshTreatment Outcome
 
dc.titleCombination of a cyclo-oxygenase-2 inhibitor and a proton-pump inhibitor for prevention of recurrent ulcer bleeding in patients at very high risk: a double-blind, randomised trial
 
dc.typeArticle
 
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<description.abstract>Background: Guidelines on pain management recommend that patients at risk of ulcers receive either a cyclo-oxygenase (COX 2) inhibitor or a non-steroidal anti-inflammatory drug (NSAID) with a proton-pump inhibitor (PPI). These two treatments have similar effectiveness, but they are insufficient for protection of patients at very high risk for ulcer bleeding. We aimed to test the hypothesis that in patients with previous ulcer bleeding induced by non-selective NSAIDs, combined treatment with the COX 2 inhibitor celecoxib and the PPI esomeprazole would be better than celecoxib alone for prevention of recurrent ulcer bleeding. Methods: 441 consecutively presenting patients who were taking non-selective NSAIDs for arthritis were recruited to our single-centre, prospective, randomised, double-blind trial after admission to hospital with upper-gastrointestinal bleeding. Patients were enrolled after their ulcers had healed and a histological test for Helicobacter pylori was negative. All patients were given 200 mg celecoxib twice daily. 137 patients were randomly assigned to receive 20 mg esomeprazole twice daily (combined-treatment group), and 136 to receive a placebo (control group) for 12 months. The primary endpoint was recurrent ulcer bleeding during treatment or within 1 month of the end of treatment. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00365313. Findings: Combination treatment was more effective than celecoxib alone for prevention of ulcer bleeding in patients at high risk. The 13-month cumulative incidence of the primary endpoint was 0% in the combined-treatment group and 12 (8&#183;9%) in the controls (95% CI difference, 4&#183;1 to 13&#183;7; p=0&#183;0004). The median follow-up was 13 months (range 0&#183;4-13&#183;0). Discontinuation of treatment and the incidence of adverse events were similar in the two treatment groups. Interpretation: Patients at very high risk for recurrent ulcer bleeding who need anti-inflammatory analgesics should receive combination treatment with a COX 2 inhibitor and a PPI. Our findings should encourage guideline committees to review their recommendations for patients at very high risk of recurrent ulcer bleeding. &#169; 2007 Elsevier Ltd. All rights reserved.</description.abstract>
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Author Affiliations
  1. United Christian Hospital Hong Kong
  2. Chinese University of Hong Kong